NCT04607044|TerminatedResultsFDA Device
Study Stopped
Sponsor decision
Lower Extremity Fixation In Neuropathic Patients Study
FINS
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Sponsor decision
FINS
Sponsor study identifier
observational
45
1 country
3
Study Start
February 3, 2021
Actual (reported)Primary Completion
October 28, 2022
Actual (reported)Study Completion
October 28, 2022
Actual (reported)Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM of 200 patients with up to 10 sites
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 28, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2020
Actual (reported)October 28, 2020
Actual (reported)February 3, 2021
Actual (reported)October 28, 2022
Actual (reported)October 28, 2022
Actual (reported)January 9, 2025
Actual (reported)Survival Analysis of Implants at 1 Year
Compare the pooled cumulative 3-year amputation (above or below the knee) rate of neuropathic patients implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM derived from a Kaplan-Meier survival analysis to a performance goal.
1 years
EQ-5D-5L- Index
1 year
FAAM-ADL
1 years
Survival Analysis of Implants at 5 Years
5 years
Radiographic Assessment
5 years
EQ-5D-5L-VAS
1 Year
Wright Medical's lower extremity devices used to treat neuropathic patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Neuropathic Patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di Plating System, VALOR™ NAIL, HOFFMANN® LRF SYSTEM and/or T2® ICF SYSTEM
Florida Joint Care Institute
Trinity, Florida, 34655, United States
Premier Orthopaedic and Sports Medicine
West Chester, Pennsylvania, 19380, United States
Central Tennessee Foot and Ankle Center
Sparta, Tennessee, 38583, United States
As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.
Rebecca Gibson
Stryker Trauma and Extremities
45 participants (actual enrollment reported by the registry).
First Submitted
October 13, 2020
First Posted
October 28, 2020
Study Start
February 3, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 28, 2022
Actual (reported)Study Completion
October 28, 2022
Actual (reported)Last Updated
January 9, 2025
Results First Posted
January 9, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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